chi-902 for treatment of social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: no substantial clinical trials of cannabidiol (cbd) in social anxiety disorder (sad) have yet been conducted. this randomized doubleblind, placebo-controlled trial of cbd in adults with sad will evaluate the efficacy, tolerability and safety of cbd oil (chi-902) in sad. in addition, the effects of treatment with chi-902 on the endocannabinoid system (ecs) will be assessed by evaluating peripheral endocannabinoids (arachidonoylethanolamide/anandamide (aea) and 2-arachidonoyl glycerol (2-ag)) before and after treatment.

this study will evaluate efficacy, therapeutic effects, tolerability and safety of cbd oil in adults with sad through a randomized placebo-controlled study design and will evaluate effects of chi-902 on peripheral endocannabinoids (aea and 2-ag). this study will be the first randomized, double-blind placebo-controlled trial conducted with chi-902 in adults with sad. the study is designed to: * evaluate the efficacy of chi-902 versus placebo in adults with sad. * evaluate the tolerability and safety versus placebo of chi-902 in adults with sad. * explore the effects of chi-902 versus placebo on different biomarkers in subjects with sad.

Eligibility criteria:
inclusion criteria: adult males or females (≥18 years of age) will be enrolled until the required number of n=160 subjects completing all study procedures is met. individuals will be included if they: 1. meet dsm-5 criteria for sad 2. score \>60 on the liebowitz social anxiety scale (lsas) exclusion criteria: 1. serious, unstable medical condition including but not limited to cerebrovascular, renal, hepatic, coronary heart disease, coagulation/blood disorders, use of anticoagulant medication, pre-existing cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or heart failure; 2. past or current neurological illness or head trauma; 3. history of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (cluster a or b); 4. current moderate or severe major depressive episode, panic disorder, generalized anxiety disorder, or post-traumatic stress disorder (ptsd). traits associated with these disorders are permissible but full dsm criteria should not be met; 5. current psychotic symptoms; 6. current suicidal ideation or suicide attempt or self-harm behavior in the past year; 7. current unstable psychiatric condition; 8. substance use disorder in the past 6 months except nicotine 9. cannabis use or use of medications or drugs targeting endocannabinoid system including but not limited to nabiximols, nabilone, or synthetic cannabinoids in the past 3 months; 10. regular pharmacological treatment with psychotropic medications except benzodiazepines which may be used as a rescue medication 11. pharmacological treatment with medications with potential significant drug-drug interactions with cbd through cytochrome p450 metabolization (cyp3a4, cyp2c9, cyp2c19, cyp1a1) based on the investigator assessment; 12. pregnancy or lactation; 13. males and females of child-bearing potential must be using and willing to continue using medically acceptable contraception throughout the study to avoid pregnancy during the study and for up to 4 weeks after study completion, as described below. study-acceptable methods of birth control are double-barrier methods, which include a combination of any 2 of the following: oral contraceptives, diaphragm, condom, copper intrauterine device, sponge, spermicide, or (partner's) vasectomy; 14. positive urine during drug screening for drugs of abuse (except benzodiazepines); 15. reported history of difficulty with intravenous blood draws; 16. allergy to or intolerability of cannabinoids, cbd or other ingredients of the product; 17. baseline liver, renal, or hematological laboratory abnormalities.

Keywords: anxiety cannabis cannabidiol cbd